ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s Quality Management System. This two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process. It includes practical instruction, case study exercises and a competency assessment.

Organiser: NSF

Location: Virtual

Contact: https://www.nsf.org/training/series/iso-149712019-practical-application-of-risk-management-to-medical-devices